November 27, 2015

The passing of Dr. Frances Kelsey at 101

Reuel S. Amdur

The recent passing of Dr. Frances Kelsey at the age of 101 in London Ontario is an occasion for remembering her courage in saving families of having seriously deformed children due to pregnant women taking thalidomide during pregnancy.

Kelsey,
a Canadian, began her service in 1960 with the U.S. Food and Drug
Administration as a reviewer for drug approvals. Soon she was asked to look at thalidomide, a
drug for pregnant women suffering from morning sickness and insomnia. She demanded evidence of its safety. The evidence was not forthcoming, and she dug
her heels in.

Thalidomide
was approved in Canada and Europe, with tragic consequences. These consequences became clear in
1961—babies born blind, with defective or missing limbs, and other defects.

Kelsey
was just a civil servant with the courage to a corporation that brought as much
pressure as it could on her. She held
her ground. As a result, the impact of
the drug on infants in the United States was limited. The U.S. distributor was able to provide free
samples to doctors, resulting in some cases of infant deformity in the United
States but the worst consequences were averted.

In
addition to protecting the birth of deformed infants, her efforts also helped
the Kennedy administration to toughen up the regulations of the Food and Drug
Administration.

Canada
has had a somewhat parallel situation.
Linda Keen, unlike Kelsey, had a top position in her operation. She was President and Chief Operating Officer
of the Canadian Nuclear Safety Commission.
Also unlike Kelsey, she was far from being a newbie. She was a career civil servant with some 20
years of service. However, like Kelsey,
she refused to buckle to illegitimate pressure and insisted on adhering to
standards to protect the public.

Her
baptism of fire came in 2007. Atomic
Energy of Canada Limited had shut down the Chalk River nuclear reactor for
routine maintenance. The reactor was
old, passed its replacement date, and the government was loathe to provide the
money to develop new facilities. Keen
balked at the situation and ruled that restarting the reactor in the state of
the then state of the facility presented an unacceptable level of risk, due to
coolant pumps not being connected to a backup energy supply. Earthquakes occur in the Chalk River area
from time to time.

As Chalk
River has been the source of medical isotopes, the shutdown was serious both in
Canada and elsewhere in the world reliant on the isotopes. So even while she and the Commission found
that the risk was unacceptably high, Parliament decided that because of the
need for the isotopes it was necessary nonetheless to restart the reactor. Beginning in November 2007, it was restarted
on December 16 of that year.

Chalk
River has not been immune to problems with the reactor. It had nuclear accidents in 1952 and
1958. On December 5, 2008, the reactor
was shut down again till December 11, due to a leakage of heavy water. Then the same problem, worse this time, led
to a shut down from May 2009 to August 2010, causing a major isotope shortage.

The
Harper government’s approach has been to privatize the mess, with substantial
subsidization from the taxpayer. It
wants the problem out of the government’s hands and out of responsibility.

So let’s
get back to Kelsey and Keen. Kelsey,
this newbie in the U.S. Food and Drug Administration, has been recognized and
honored. Hired in 1960, on August 8,
1962, President John F. Kennedy personally presented her with the Distinguished
Federal Civil Service Medal. As noted,
her brave stand led to tighter drug approval regulations.

And
Keen? She was castigated by Prime
Minster Harper. Gary Lunn, then Minister
of Natural Resources, told her that the government had lost confidence I her
and forced her removal.

In 2008,
she appeared before the Natural Resources Committee of Parliament. On that occasion, Liberal MP Omar Alghabara
told her, “For no other reason, from what I can see, than purely political
reasons, unfortunately your name and reputation have been dragged through the
mud by this Prime Minister.”

Keen was
made a scapegoat for the government’s failure to maintain and replace the Chalk
River reactor and to maintain an adequate production of medical isotopes. Various workarounds are in place and a new
facility is planned in the Netherlands.

Frances
Kelsey has been showered with praise and awards, including being names to the
Order of Canada. Keen has been smeared
by her own government, by Minister Lunn in particular. She performed her services to Canada
faithfully and honorably, refusing to abandon her duty in the face of Harper’s
pressure and denunciations. But even
after leaving her post she continues to promote the public interest.

Gary
Lunn was MP for Saanich-Gulf Islands in British Columbia. In the 2011 electoral campaign, Linda Keen
gave her support to Green Party leader Elizabeth May, who went on to defeat
Lunn. Keen provided a public service by
refusing to back down on her conclusion about the safety risk at Chalk River. She performed another in helping to retire a
particularly nasty Member of Parliament.

Will a
new government give her the recognition to which she is surely entitled? Canada made Kelsey a member of the Order of
Canada. Why not Keen?